DENVER, NYPosted a month ago

Job summary

• Job post source

  This job is directly from Cleerly

• Job overview

  The Principal Regulatory Affairs Specialist at Cleerly leads regulatory strategy and compliance for AI/ML-based medical devices, ensuring global market authorization and supporting product development.

• Responsibilities and impact

  The role involves preparing and submitting regulatory documents globally, liaising with authorities, managing regulatory information, supporting product development teams with regulatory guidance, ensuring compliance with evolving AI/ML and SaMD regulations, monitoring regulatory policies, and mentoring senior regulatory staff.

• Compensation and benefits

  Total Target Compensation ranges from $210,000 to $240,000 depending on location, including base pay and bonuses; benefits details are not specified.

• Experience and skills

  Requires a B.S. or higher in Life Science or Engineering, 7+ years in medical device regulatory affairs, 3+ years with AI/ML or SaMD devices, knowledge of global regulations, strong communication, and preferred RAC certification.

• Career development

  Opportunities include mentoring senior professionals and working on cutting-edge AI/ML medical device regulatory challenges, supporting professional growth in a fast-growing healthcare company.

• Work environment and culture

  Cleerly values humility, excellence, accountability, innovation, and teamwork, with a remote-friendly environment and offices in multiple US cities and Lisbon, Portugal.

• Company information

  Cleerly is a healthcare company founded in 2017 focused on AI-driven heart disease diagnostics, backed by over $300M in funding, conducting large clinical trials and innovating in precision diagnostics.

• Job location and travel

  The role is remote with office access in Denver, NYC, Dallas, and Lisbon; some roles may require onsite presence.

• Application process

  Applicants agree to receive SMS messages during the interview process; official communications come from @cleerlyhealth.com; no specific application steps detailed.

• Unique job features

  The job focuses on AI/ML and Software as a Medical Device regulatory strategy, a cutting-edge area in medical device regulation, with a strong emphasis on global regulatory compliance and innovation.

Company overview

Cleerly is a healthcare technology company specializing in advanced cardiovascular imaging and diagnostics. They leverage artificial intelligence to analyze coronary CT angiography, providing detailed insights into heart disease that help physicians make informed treatment decisions. Founded in 2017, Cleerly aims to revolutionize cardiovascular care by offering precise, non-invasive diagnostic tools. Their revenue model primarily includes partnerships with healthcare providers and licensing their AI-driven software solutions. Notably, Cleerly has garnered significant attention for its innovative approach to tackling one of the leading causes of death globally.

How to land this job

• Position your resume to highlight your expertise in regulatory affairs for AI/ML-based medical devices and software as a medical device (SaMD), emphasizing your experience with global regulatory submissions and strategy development.

• Focus on showcasing your ability to manage regulatory compliance across multiple regions (US, EU, APAC) and your skills in preparing and liaising on submissions with agencies like FDA, Health Canada, and European authorities.

• Apply through multiple platforms including Cleerly’s corporate career site, LinkedIn, and other job boards where Cleerly posts openings to maximize your chances of being noticed.

• Connect on LinkedIn with professionals in Cleerly’s regulatory affairs or medical device divisions, using ice breakers such as asking about recent regulatory challenges they faced with AI/ML devices or commenting on Cleerly’s innovative AI-driven heart disease diagnostics.

• Optimize your resume for ATS by incorporating keywords from the job description such as 'regulatory submissions,' 'AI/ML medical devices,' 'global regulatory strategy,' 'SaMD,' and 'compliance,' ensuring your resume passes initial automated screenings.

• Leverage Jennie Johnson's Power Apply feature to automate tailoring your resume, identify the best application channels, and find relevant LinkedIn contacts, allowing you to focus your energy on interview preparation and networking.